A Phase I Study of Certolizumab plus Chemotherapy for Patients with Stage IV Lung Adenocarcinoma

Protocol

13-063

Full Title

A Phase I Trial of Certolizumab in Combination with Chemotherapy for Patients with Stage IV Lung Adenocarcinomas

Phase

I

Purpose

Cisplatin and pemetrexed are standard chemotherapy drugs used to treat lung cancer. Researchers hope that giving another drug called certolizumab with cisplatin and pemetrexed in patients with stage IV adenocarcinoma of the lung (a type of metastatic lung cancer) may be more effective than standard chemotherapy alone. The purpose of this study is to find the highest dose of certolizumab that can be given safely with cisplatin and pemetrexed in these patients.

Certolizumab is FDA approved for the treatment of certain inflammatory diseases, such as rheumatoid arthritis and inflammatory bowel disease, but its use in patients with lung cancer is considered investigational. It reduces inflammation by blocking a protein called tumor necrosis factor-alpha (TNF-alpha). Research has shown that blocking inflammation may make chemotherapy more effective. Certolizumab may also help prevent cancer from spreading to new organs. It is given as an injection under the skin.